Sternal osteomyelitis and poststernotomy mediastinitis is a severe and life-treating complication after the cardiac surgery. The incidence of sternal osteomyelitis ranges from 1% to 3% with a high mortality rate from 19% to 29% .

The most devastating complication of the open sternum is the laceration of the right ventricle which has a very high mortality. Additionally destabilizations of the thoracic cage, prolonged immobilization, or substantial surgical trauma are further complications of the conventional strategy (4). In addition, postoperative infections after sternotomy are associated with prolonged hospital stay, increased healthcare costs and impaired quality of patient life, representing an economic and social burden. The emergence of increasing antimicrobial resistant bacteria augments the importance of postsurgical infections since the antimicrobial choices are becoming limited. Furthermore, the incidence of infection is an indicator for the quality of patient care in the international benchmark studies.

Although several therapy strategies are nowadays present in clinical practice, there is a lack of evidence based surgical consensus for treatment of this surgical complication. In most case the poststernotomy mediastinitis is involving surgical revision with debridement, open dressing and/or vacuum assisted therapy. After the granulation tissue on open chest wound was achieved secondary closure and/or reconstruction with vascularized soft tissue flaps such as omentum or pectoral muscle is performed.

It seems there is a need for more effective surgical treatment of poststernotomy wound infections, which may address the prolonged hospitalization and reduce number of surgical interventions and with this also perioperative morbidity. In light of this we propose a randomized study comparing new delay primary closure of the sternum to the secondary vacuum assisted closure.

after the diagnosis of the poststernotomy wound infection is established the clinical procedure is obtained as follows: firstly the empiric antibiotic therapy with vancomycin is induced. The lab samples including bacteriology test are obtained. Surgical debridement is made until occurrence of tissue bleeding. Finally VAC sponge is implanted wit the negative suction pressure of 75 mmHg.

The patients are obtained 5 to 7 times to the surgical procedures in time intervals of 48/72 hours. Subsequently when the last three bacteriology samples are negative a delayed primary closure or rectus abdominal muscle flap may be done.

Procedure: Surgical closure of the poststernotomy wound infection

Arm A) Secondary closure with the vacuum-assisted system (VAC); The initial surgical revision is done within 24 hours. The first revision with second look and debridement is usually made in 72 hours Subsequently in the following days the wound is stepwise revised during VAC changes.The patients are obtained 5 to 7 times to the surgical procedures in time intervals of 72 hours. Subsequently when the last three bacteriology samples are negative a delayed primary closure or rectus abdominal muscle flap may be done.

Arm B) Surgical procedure by delayed primary closure; The patients will receive treatment delivered through the VAC system in the first 48 hours following the first surgical intervention, subsequently the wound is closed. after the sternum is closed by using metallic wires, pectoral muscle on both chest parts is mobilized and closed directly over the bone.

In the first step, after the diagnosis of the infection was done, and the empiric antibiotic therapy is induced with vancomycin in the first surgical intervention the sternal wires will be removed, the mediastinum is explored and extensive surgical debridement is performed until occurrence of tissue bleeding.The patients will receive treatment delivered through the VAC system in the first 48 hours following the first surgical intervention, subsequently the wound is closed.

Procedure: Surgical closure of the poststernotomy wound infection

Arm A) Secondary closure with the vacuum-assisted system (VAC); The initial surgical revision is done within 24 hours. The first revision with second look and debridement is usually made in 72 hours Subsequently in the following days the wound is stepwise revised during VAC changes.The patients are obtained 5 to 7 times to the surgical procedures in time intervals of 72 hours. Subsequently when the last three bacteriology samples are negative a delayed primary closure or rectus abdominal muscle flap may be done.

Arm B) Surgical procedure by delayed primary closure; The patients will receive treatment delivered through the VAC system in the first 48 hours following the first surgical intervention, subsequently the wound is closed. after the sternum is closed by using metallic wires, pectoral muscle on both chest parts is mobilized and closed directly over the bone.

Who has been operated on the open heart and received a total or partial median sternotomy

Informed consent has been obtained, subject is willing to follow protocol study treatment regimen, and comply with all planned follow-up assessments

Not self-determined patients are not exclusion criteria

Exclusion Criteria:

after heart transplantation or other orthotropic transplantation procedure

superficial wound infections (see definition at 4.1)

Sterile open wound dehiscence's without any sign of local or systematic infection.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01473979